Trial no.:
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PACTR201710002664704 |
Date of Approval:
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03/10/2017 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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Painless Vaginal Delivery |
Official scientific title |
Effect of the use of dexmedetomidine as a local anesthetic adjuvant in epidural labour analgesia: Randomized controlled study |
Brief summary describing the background
and objectives of the trial
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Although cesarean section must be just performed based on medical
indications, its rate has been growing worldwide. Fear of childbirth is one of the most important factors causing women especially nulliparous women to be interested in elective cesarean section. The severity of this fear depends on many factors, e.g. personality, history, and experiences.
Since this fear is not decreased even after psychological counseling, it is
necessary to relieve the pain of normal delivery by offered methods. Labour pain is the result of many complex physiological and psychological interactions. Pain and agony during childbirth are quite unbearable and sometimes beyond description. The pain if not adequately controlled may affect respiratory, cardiovascular, gastrointestinal, urinary and neuroendocrine functions. Pain
also reduces uteroplacental blood flow leading to altered fetal homeostasis.
Effective analgesia during labour will prevent these avoidable consequences.
According to guidelines of the American Society of Anesthesiology (ASA), and American College of Obstetrics and Gynecology (ACOG), epidural analgesia is recommended in painless labour as the most flexible, effective, and least depressing to the central nervous system of the choices available. However obstetric anesthesiologist has occasionally faced with absolute or relative
contraindication: women with higher risk for thrombosis, thromboembolism, or receiving anticoagulant therapy. Women also may ask for alternatives to central neuraxial analgesia.
Current practice in obstetric analgesia is to combine local anesthetics with adjuvant drugs in order to maintain high efficacy and comfort while reducing
individual drug doses and side effects. Alpha 2 (¿ 2) adrenergic receptor agonist, has been widely used and investigated as an analgesic adjuvant for anesthesia and pain therapy, dexmedetomidine belongs to this family but presents with a different and more favorable pharmacokinetics. |
Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
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Disease(s) or condition(s) being studied |
Painless Vaginal Delivery,Pregnancy and Childbirth |
Sub-Disease(s) or condition(s) being studied |
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Purpose of the trial |
Treatment: Drugs |
Anticipated trial start date |
12/10/2017 |
Actual trial start date |
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Anticipated date of last follow up |
11/04/2018 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
60 |
Actual target sample size (number of participants) |
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Recruitment status |
Not yet recruiting |
Publication URL |
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